Safety, Tolerability, and Pharmacokinetics of Single Doses BI 425809
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: BI 425809 PfOSDrug: PlaceboDrug: BI 425809 tablet
- Registration Number
- NCT02068690
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809 tablet fasted and tablet fed
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 83
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BI 425809 single rising dose BI 425809 PfOS BI 425809 powder for oral solution (PfOS) in single rising doses BI 425809 single rising dose Placebo BI 425809 powder for oral solution (PfOS) in single rising doses BI 425809 Crossover Placebo Bioavailability of BI 425809 PfOS BI 425809 Crossover BI 425809 tablet Bioavailability of BI 425809 PfOS BI 425809 Crossover BI 425809 PfOS Bioavailability of BI 425809 PfOS
- Primary Outcome Measures
Name Time Method frequency [N(%)] of subjects with drug related adverse events (AEs) up to 18 days
- Secondary Outcome Measures
Name Time Method Cmax (maximum measured concentration of the analyte in plasma) up to 192 hours AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) up to 192 hours
Trial Locations
- Locations (1)
1346.1.1 Boehringer Ingelheim Investigational Site
🇩🇪Ingelheim, Germany